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NCT04340531
Effectiveness of a Multi-Level Smoking Cessation Program for High-Risk Women in Rural Communities
NA trial testing Best Practice in Tobacco-Related Carcinoma in 810 participants. Participants enrolled and being followed up; not accepting new ones.
13 March 2025
Quick facts
| Lead sponsor | Ohio State University Comprehensive Cancer Center |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 810 |
| Start date | 30 January 2021 |
| Primary completion | 13 March 2025 |
| Estimated completion | 31 May 2026 |
| Sites | 4 locations across United States |
Drugs / interventions tested
- Best Practice
- Survey Administration
- Tobacco Cessation Counseling
- Tobacco Cessation Counseling
- Training
Conditions studied
- Tobacco-Related Carcinoma — all drugs for Tobacco-Related Carcinoma →
Sponsor
Ohio State University Comprehensive Cancer Center
Who can join
Adults 18 to 64, any sex, with Tobacco-Related Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase IV trial examines the effectiveness of a multi-level smoking cessation program for high-risk women in rural communities. Cigarette smoking is a major risk factor for cervical cancer in women. Rural primary care practices and providers often lack the electronic health record support to pre-identify smokers for services, as well as lack the necessary counseling training and access to comprehensive cessation programs. Implementing evidence-based smoking cessation programs in rural Appalachia may decrease the rates of cigarette smoking and as a result decrease the rates of cervical cancer.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
A cluster randomized controlled trial for a multi-level, clinic-based smoking cessation program with women in Appalachian communities: study protocol for the "Break Free" program.
Patterson JG, Borger TN, Burris JL, Conaway M, et al · · 2022 · cited 4× · PMID 35164857 · DOI 10.1186/s13722-022-00295-5 -
Appalachian Primary Care Patients' Quit Readiness and Tobacco Treatment Receipt.
Burris JL, Feather AR, Pilehvari A, Cooper S, et al · · 2025 · cited 1× · PMID 39343324 · DOI 10.1016/j.amepre.2024.09.017
Verify or expand the search:
- PubMed search for NCT04340531
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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Other Ohio State University Comprehensive Cancer Center trials
Trials by the same sponsor.
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- NCT07455513 — A Novel Tobacco Cessation Resource for Smokers With a Diagnosed or Suspected Thoracic Cancer · NA · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04340531 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center
- Last refreshed: 1 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04340531.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing